Recruiting

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT00700414

Conditions

Adrenocortical Tumor

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This study aims to collect demographic and medical information including detailed family history of cancer of children and adolescents with adrenocortical tumors in order to learn more about the clinical and epidemiological aspects, treatment modalities, and outcome of patients with this rare disease, worldwide.

In addition, investigators at St. Jude Children's Research Hospital (SJCRH) plan to perform molecular studies of tumor cells aimed to clarify the role of the TP53 gene and other genetic pathways in these tumors. They aim to obtain relevant biological material from participants with adrenocortical tumor (ACT), their biological parents, and relatives for determination of the TP53 germline status, molecular studies of the TP53 gene, and other molecular pathways.

Conditions

Adrenocortical Tumor

Study ID

NCT00700414

Start date

Oct 1, 2001

Status verified date

May, 2026

Completion date

Dec, 2040

Anticipated

Primary completion date

Dec, 2040

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

STRATIFICATION ASSIGNMENT:

  • Stratum A: participant suspected or confirmed diagnosis of adrenocortical tumor (ACT)
  • Stratum R: relative of participant with ACT and TP53 mutation who has diagnosis of malignancy
  • Stratum P: biological parent of participant with ACT

Inclusion Criteria - Stratum A (participant with ACT):

  • Age ≤ 21 years old at diagnosis
  • Suspected or confirmed diagnosis of adrenocortical tumor (adenoma, carcinoma or undefined histology).
  • Signed informed consent

Inclusion Criteria - Stratum R (relative):

  • Any age
  • Diagnosis of malignant tumor
  • Signed informed consent

Inclusion Criteria - Stratum P (parent):

  • Biological parent of Stratum A participant

Study Design

Enrollment

9999 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants

Any participant who meets eligibility criteria and consents to participate in the trial.

Primary outcome measure

  • Collect demographic/medical information, detailed family history of cancer of children/adolescents with adrenocortical tumors, learn more about the clinical and epidemiological aspects, treatment modalities, and outcome of patients [ Time Frame: Annually from diagnosis until no longer being followed, defined as up to 5 years from the date of last follow-up ]

Central Contacts and Locations

Central contacts

Raul C Ribeiro, MD

866-278-5833referralinfo@stjude.org

Locations

The Children's Medical Center

Recruiting

Dayton, Ohio, United States, 45404

Principal Investigator:

Mukund Dole, MD

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Raul C Ribeiro, MD

866-278-5833referralinfo@stjude.org

Principal Investigator:

Raul C Ribeiro, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-05-22.